Z-0111-2016Class II

Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN...

Name: Z-0111-2016 Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN...
Creator: DePuy Orthopaedics, Inc.
Published: 2015-09-08
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2015-09-08 / Terminated / root cause: design

FDA source

DePuy Orthopaedics, Inc. began a recall of Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C... on 2015-09-08. FDA classified it as Class II and gives the reason as "DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary Rod 400mm Instrument (PN 96-6120) due to complaints of the rod fracturing and leaving a portion of the rod in...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0111-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-08
Posted: 2015-10-07
Terminated: 2018-07-03
Recalling firm: Depuy Orthopaedics Inc.
Product: Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C. SIGMA knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included with the P.F.C. SIGMA Specialist 2 (SP2 / SPII) Primary Knee Instruments, the P.F.C. SIGMA Specialist 2 (SP2 / SPII) Revision Knee Instruments, and P.F.C. SIGMA High Performance (HP) Primary Knee Instruments
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary Rod 400mm Instrument (PN 96-6120) due to complaints of the rod fracturing and leaving a portion of the rod in patients.
Root cause tag: design
FDA root cause: Device Design
Action: DePuy Synthes sent an Urgent Information Recall Notice to all affected customers. Instruments are not lot traceable in the system, so the company sent notices by e-mail on September 8, 2015, and US Distributors will hand deliver notices to all Medical Facilities that may have purchased the affected instrument. The US Distributor or US Sales Consultant will deliver the Medical Professional Notice and Reconciliation Form to the affected Medical Facilities. If assistance is needed, Sales Consultants will assist customers with inspection of all instruments, return of affected lots, receiving credit and returning the completed Medical Facility Reconciliation Forms to DePuy Orthopaedics, Inc. The affected instruments will be returned to the quarantine warehouse located at 700 Orthopaedic Drive, Warsaw, IN 46582. For questions regarding this recall call 574-371-4917. For questions regarding this recall call 574-267-8143.
Quantity in commerce: 7488
Distribution: Worldwide Distribution - US including AL; AZ; CA; CO; CT; DC; FL; GA; HI; IA; IL; IN; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; NE; NH; NJ; NV; NY; OH; OR; PA; RI; SC; TN; TX; UT; VA; VT; WA; WI; and WV and Internationally to ARGENTINA; AUSTRALIA; AUSTRIA; BELGIUM; BRAZIL; CANADA; CHILE; COLOMBIA; CZECH REPUBLIC; EGYPT; FRANCE; GERMANY; GREECE; INDIA; ISRAEL; ITALY; KOREA; Mexico; NEW ZEALAND; NORWAY; P R CHINA; PANAMA; PERU; POLAND; RUSSIA; SINGAPORE; SLOVENIA; SOUTH AFRICA; SWITZERLAND; UAE; UK; URUGUAY; VENEZUELA; and VIETNAM.
Product codes and lots: SP2 IM Rod 400mm Instruments (96-6120) manufactured with 455 stainless steel (SS) or 17-4 SS; CATALOG NO. : 96-6120; GTIN NO.: 10603295246893; Lots: Manufactured with 455 Stainless Steel, Labeled Lot #s-C98CS4; DE5P34; DE5RP4; D95AN4; EB5FV4; FA4G94; DE1FA4; DF4H44; DG9LK4; EB5GH4; EC9JY4; EF4DJ4; FD8MP4; FH8JA4; DG9L64; DJ5E34; DK3E34; EJ7AP4; DK3FE4; EJ7A34; ES2G64; ES2HA4; FH8JX4; ES2HY4; EX5L44; C3JHN4; EX5MS4; C3JHS4; E2SD44; C3JHF4; C4GA54; C4GBT4; C4GCC4; C52F14; C52F74; C52GL4; C52GV4; C67N14; C98BF4; TBACC; TBACZ; FJ4E74; TBCOJ; & Manufactured with 17-4 Stainless Steel- Etched Lot #s- H0797; H0100; H0199; H0200; H0298; H0301; H0396; H0399; H0401; H0495; H0499; H0530; H0596; H0598; H0600; H0601; H0696; H0699; H0796; H0797; H0800; H0899; H0900; H0997; H0998; H1095; H1097; H1195; H1198; H1297; H1298; H1299

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0111-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0111-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-07

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)